Inglés

Eligibility Breast Neoplasms NCT01649271

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients aged 18 years and older
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
2. patients with cancers overexpressing her2 by immunohistochemistry test( ihc) 3+
Descripción

Neoplasm HER2 Overexpression Immunohistochemistry

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0069515
UMLS CUI [1,3]
C1514559
UMLS CUI [1,4]
C0021044
and/or ihc 2+ with positive gene amplification by fish (confirmation on archived tissue needed)
Descripción

Immunohistochemistry | HER2 gene amplification Positive FISH | Confirmation Tumor tissue sample

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021044
UMLS CUI [2,1]
C1512127
UMLS CUI [2,2]
C1514241
UMLS CUI [2,3]
C0162789
UMLS CUI [3,1]
C0750484
UMLS CUI [3,2]
C0475358
3. written informed consent that is consistent with ich-gcp guidelines.
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
4. patients must be eligible for treatment with trastuzumab.
Descripción

Patient Eligible Trastuzumab

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548635
UMLS CUI [1,3]
C0728747
5. patients must have adequate organ function (kidney, liver, bone marrow, cardiac)
Descripción

Organ function | Renal function | Liver function | Bone Marrow function | Cardiac function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
UMLS CUI [4,1]
C0005953
UMLS CUI [4,2]
C0031843
UMLS CUI [5]
C0232164
6. eastern cooperative oncology group (ecog) = 0 or 1.
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
7. measurable disease according to recist 1.1 (phase ib).
Descripción

Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. active brain metastases.
Descripción

Metastatic malignant neoplasm to brain

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0220650
2. prior treatment with erbb family targeting therapies within the past four weeks before start of therapy or concomitantly with the trial other than trastuzumab and/or lapatinib.
Descripción

Targeted Therapy ErbB Receptors | Exception Trastuzumab | Exception Lapatinib

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C2985566
UMLS CUI [1,2]
C3812393
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0728747
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1506770
3. patients having more than 2 lines of chemotherapy for the treatment of metastatic breast cancer (phase ib).
Descripción

Chemotherapy Quantity Secondary malignant neoplasm of female breast

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0346993
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Similar models

Eligibility Breast Neoplasms NCT01649271

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. patients aged 18 years and older
boolean
C0001779 (UMLS CUI [1])
Neoplasm HER2 Overexpression Immunohistochemistry
Item
2. patients with cancers overexpressing her2 by immunohistochemistry test( ihc) 3+
boolean
C0027651 (UMLS CUI [1,1])
C0069515 (UMLS CUI [1,2])
C1514559 (UMLS CUI [1,3])
C0021044 (UMLS CUI [1,4])
Immunohistochemistry | HER2 gene amplification Positive FISH | Confirmation Tumor tissue sample
Item
and/or ihc 2+ with positive gene amplification by fish (confirmation on archived tissue needed)
boolean
C0021044 (UMLS CUI [1])
C1512127 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0162789 (UMLS CUI [2,3])
C0750484 (UMLS CUI [3,1])
C0475358 (UMLS CUI [3,2])
Informed Consent
Item
3. written informed consent that is consistent with ich-gcp guidelines.
boolean
C0021430 (UMLS CUI [1])
Patient Eligible Trastuzumab
Item
4. patients must be eligible for treatment with trastuzumab.
boolean
C0030705 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0728747 (UMLS CUI [1,3])
Organ function | Renal function | Liver function | Bone Marrow function | Cardiac function
Item
5. patients must have adequate organ function (kidney, liver, bone marrow, cardiac)
boolean
C0678852 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0005953 (UMLS CUI [4,1])
C0031843 (UMLS CUI [4,2])
C0232164 (UMLS CUI [5])
ECOG performance status
Item
6. eastern cooperative oncology group (ecog) = 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Measurable Disease
Item
7. measurable disease according to recist 1.1 (phase ib).
boolean
C1513041 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain
Item
1. active brain metastases.
boolean
C0220650 (UMLS CUI [1])
Targeted Therapy ErbB Receptors | Exception Trastuzumab | Exception Lapatinib
Item
2. prior treatment with erbb family targeting therapies within the past four weeks before start of therapy or concomitantly with the trial other than trastuzumab and/or lapatinib.
boolean
C2985566 (UMLS CUI [1,1])
C3812393 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0728747 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1506770 (UMLS CUI [3,2])
Chemotherapy Quantity Secondary malignant neoplasm of female breast
Item
3. patients having more than 2 lines of chemotherapy for the treatment of metastatic breast cancer (phase ib).
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0346993 (UMLS CUI [1,3])
Volver a la parte superior de la página